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Trial Title: Evaluating the Role of ChatGPT in Educating Patients With Early-stage Hepatocellular Carcinoma

NCT ID: NCT06384950

Condition: Carcinoma, Hepatocellular

Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular

Conditions: Keywords:
ChatGPT
Patient Education

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: To compare the educational effectiveness of a chatbot integrated with health education information to traditional health education methods. This comparison encompassed aspects such as the patient's health literacy and clinical satisfaction. Based on the findings, recommendations and improvements would be proposed to promote the application and development of large language models in the medical field.

Primary purpose: Health Services Research

Masking: Single (Participant)

Masking description: The research uses a Randomized Controlled Trial (RCT) methodology, dividing patients into a control group undergoing the conventional patient education routine, and an experimental group that leverages both the chatbot and traditional education. By comparing selected outcomes between the two groups, the experiment's effectiveness will be determined.

Intervention:

Intervention type: Behavioral
Intervention name: ChatGPT
Description: Patients receive additional education using a GPT-3.5-based educational robot on top of the traditional education.
Arm group label: GPT-3.5-based educational

Other name: Add GPT-3.5 model for patient education

Intervention type: Behavioral
Intervention name: patient education with traditional methods.
Description: Patients receive standard traditional education procedures.
Arm group label: Traditional education procedures

Summary: Liver cancer is a leading cause of cancer-related deaths in Taiwan, with its onset linked to factors like chronic liver conditions, cirrhosis, and genetic predispositions. According to the "Barcelona Clinic Liver Cancer (BCLC)" classification, early-stage liver cancer is demarcated by stages 0 to A. Upon such diagnosis, both patients and their families often have numerous questions and concerns, ranging from treatment choices to long-term outcomes. The research proposes a GPT-3.5-based chatbot to assist these patients by providing timely, personalized information, aiming to enrich their understanding of the disease and improve communication between patients and health professionals. The research methodology employs a Randomized Controlled Trial (RCT) design, dividing participants into a control cohort receiving standard patient education routine and an experimental cohort receiving both the AI chatbot and traditional education routine. The comparative analysis of these cohorts will determine the effectiveness of the AI intervention in improving patients' health literacy and satisfaction.

Detailed description: Liver cancer is the second most common cause of cancer-related deaths in Taiwan. Various factors play a role in its development, such as chronic liver conditions, cirrhosis, viral infections, alcohol intake, obesity, diabetes, and genetic predispositions, among others. Based on the "Barcelona Clinic Liver Cancer (BCLC)" system, early-stage liver cancer falls within stages 0 to A. When faced with an early-stage liver cancer diagnosis, patients and their relatives frequently express concerns. These may range from the potential effects of the disease on daily living, evaluating treatment options, potential side effects, costs involved, the chances of recurrence, and survival rates, to the care required after the treatment. Addressing these worries often requires extensive explanations and time for the patients to process the information. The research proposes using a chatbot built upon the GPT-3.5 language model developed by OpenAI for patient education services. Such a chatbot would aid early-stage liver cancer patients navigate the complexities of obtaining relevant information. As an artificial intelligence technology, the chatbot can offer timely, personalized information and psychological support. By responding to patients' inquiries, the chatbot can provide a thorough understanding of basic liver cancer knowledge, its causes, and treatment approaches, thereby facilitating a deeper comprehension of the early stages of liver cancer and its treatment regimen. Patients and their relatives can comprehend their condition and treatment plans, enhancing their conversations with medical staff and promoting a harmonious doctor-patient relationship. The research uses a Randomized Controlled Trial (RCT) methodology, dividing patients into a control group undergoing the conventional patient education routine, and an experimental group that leverages both the chatbot and traditional education. By comparing selected outcomes between the two groups, the experiment's effectiveness will be determined.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Patients with early-stage hepatocellular carcinoma from both gastroenterology and general surgery outpatient departments were included. Early-stage hepatocellular carcinoma is defined based on the Barcelona Clinic Liver Cancer (BCLC) staging as stages 0 to A. Exclusion Criteria: - Patients under the age of 18 or those currently undergoing treatment for other cancers.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Taipei Veterans General Hospital

Address:
City: Taipei
Zip: 11217
Country: Taiwan

Status: Recruiting

Contact:
Last name: Chun-Ying Wu

Phone: +886-28712121

Phone ext: 4190
Email: chptaiwan07@gmail.com

Contact backup:
Last name: HSIAO-PING CHEN

Phone: +886-28712121

Phone ext: 4190
Email: chptaiwan07@gmail.com

Start date: March 22, 2024

Completion date: March 21, 2025

Lead sponsor:
Agency: Taipei Veterans General Hospital, Taiwan
Agency class: Other

Source: Taipei Veterans General Hospital, Taiwan

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06384950

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